FDA Inspection
SCARLETH RESEARCH, LLCSCARLETH RESEARCH, LLC – FDA Inspection, Apr 22, 2025
Record Details
This FDA Inspection record concerns SCARLETH RESEARCH, LLC, with an inspection on April 22, 2025, issued by the Florida District Office, covering foods & cosmetics.
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ID · ddfaaaeb-af72-4646-813e-48219f3b860e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1229737
- FDA center
- Foods & Cosmetics
- Project area
- Foodborne Biological Hazards
- Outcome
- Form 483 issued
FDA Citations
13- 21 CFR 111.103Written procedures - establish; quality control operations
- 21 CFR 111.140(b)(3)Records - material review, follow-up
- 21 CFR 111.205(a)Master manufacturing record - prepared
- 21 CFR 111.255(a)Batch record - every batch
- 21 CFR 111.260Batch record - required information
- 21 CFR 111.35(b)Make and keep records - equipment and utensils
- 21 CFR 111.475(b)Records - written procedures holding and distribution; product distribution
- 21 CFR 111.535(b)Make and keep records - returned dietary supplements
- 21 CFR 111.570(b)Records - written procedures; product complaint
- 21 CFR 111.70(b)Specifications - components
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